Valeris Medical, LLC: Medical Device Recall in 2018 - (Recall #: Z-2430-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair

Product Classification:

Class II

Date Initiated: January 22, 2018

Date Posted: July 25, 2018

Recall Number: Z-2430-2018

Event ID: 80069

Reason for Recall:

The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.

Status: Terminated

Product Quantity: 113 units

Code Information:

Model No. XT-5515, Lot No. 2358, 2362, 2363

Distribution Pattern:

US Nationwide Distribution in the states of California and Oklahoma.

Voluntary or Mandated:

Voluntary: Firm initiated